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Volunteers in Research and Testing by Bryony Close, R. Coomber, Anthony Hubbard, John Illingworth

By Bryony Close, R. Coomber, Anthony Hubbard, John Illingworth

This article discusses using volunteers, both fit or present process remedy, within the examine and checking out of medicinal and non-medicinal items. the level to which the enhanced use of such volunteers might lessen the necessity for animal exams is

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I needed him to say that he knew the best treatment for me’ (Alderson, 1993). Learning about medical uncertainty comes as an additional shock to patients who already feel trapped in terrifying uncertainties. Randomisation is a very difficult technique for lay people to accept. It signifies that treatment will be decided as a matter of chance. Patients want treatment tailored to their specific requirements. Randomisation disregards their individual uniqueness. It depersonalises patients. Furthermore, it asks them to put aside their own concerns and consider the interests of unknown people who in the future may suffer from the same disease.

Can the ethics committee that is set up to approve protocols be the appeal committee should any patient or volunteer wish to approach someone for independent advice? If so, can this be written into an agreement? This could be written in but the average ethics committee is overwhelmed in terms of the business that it has participated in and therefore if you add another strand to their responsibilities it may be almost impossible to get people to serve on those committees. If an independent advice group is required it would be better to construct it independently.

Discussions have taken place as to whether there should be a form of licensing and register for conducting studies on normal volunteers, comparable to what happens with animal experimentation. However, it would be very difficult to police properly. Therefore it has largely been left up to ethical committees and/or the code of practice of the Association of the British Pharmaceutical Industry (ABPI) who are themselves extremely concerned about volunteer usage and who would be implicated in any litigation if unnecessary risks occurred and patients were damaged.

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